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Checkpoint Inhibitor

Nivolumab Combination Therapy for Colorectal Cancer (CheckMate142 Trial)

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Histologically confirmed recurrent or metastatic colorectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (approximately up to 34 months)
Awards & highlights

CheckMate142 Trial Summary

This trial will test if Nivolumab can effectively treat colon cancer that has returned or spread, specifically in patients whose tumors have a certain biomarker.

Who is the study for?
This trial is for adults with colorectal cancer that has returned or spread, and who haven't been treated for metastatic disease. They should be relatively active (ECOG 0-1), have measurable disease, and tumors with a specific biomarker (microsatellite instability). People can't join if they've had certain cancers in the last 3 years, need steroids or other immune-suppressing drugs, have autoimmune diseases, brain metastases, or previous treatments targeting immune checkpoints.Check my eligibility
What is being tested?
The study tests whether Nivolumab alone or combined with Daratumumab, Ipilimumab, BMS-986016, or Cobimetinib shrinks tumors in colon cancer patients. It's exploring different mixtures of these drugs to see which might work best at reducing tumor size when the standard treatment isn’t enough.See study design
What are the potential side effects?
Nivolumab and its combination therapies may cause fatigue, skin reactions like rash or itching; gastrointestinal issues such as diarrhea; liver problems; hormonal gland changes leading to mood swings or tiredness; inflammation of organs like lungs causing coughing or shortness of breath.

CheckMate142 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My colorectal cancer has returned or spread to other parts.
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My cancer shows microsatellite instability.

CheckMate142 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (approximately up to 34 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and the final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (approximately up to 34 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Secondary outcome measures
ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC)

CheckMate142 Trial Design

6Treatment groups
Experimental Treatment
Group I: Nivolumab MonotherapyExperimental Treatment1 Intervention
Nivolumab administered as IV infusion at a dose of 3mg/kg every 2 weeks until disease progression
Group II: Nivolumab + Ipilimumab Cohort C3Experimental Treatment2 Interventions
Group III: Nivolumab + Ipilimumab + Cobimetinib Cohort C4Experimental Treatment3 Interventions
Group IV: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group V: Nivolumab + Daratumumab Cohort C6Experimental Treatment2 Interventions
Group VI: Nivolumab + BMS-986016 Cohort C5Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Daratumumab
2014
Completed Phase 3
~1860
Ipilimumab
2014
Completed Phase 3
~2640
BMS-986016
2018
Completed Phase 2
~130
Cobimetinib
2015
Completed Phase 3
~2630

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,125,931 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02060188 — Phase 2
Colorectal Cancer Research Study Groups: Nivolumab + Ipilimumab + Cobimetinib Cohort C4, Nivolumab Monotherapy, Nivolumab + Ipilimumab, Nivolumab + Ipilimumab Cohort C3, Nivolumab + Daratumumab Cohort C6, Nivolumab + BMS-986016 Cohort C5
Colorectal Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02060188 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02060188 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health concerns does Nivolumab treatment address?

"Nivolumab is conventionally employed to manage unamenable melanoma, as well as squamous cell carcinoma and hematopoietic stem-cell transplants which have not responded to a previous treatment."

Answered by AI

Are there any regional sites hosting this clinical research?

"Presently, this trial has 34 separate locations available for enrollment; some of the most common cities are Minneapolis, Portland and Atlanta. To reduce travel strains it would be beneficial to select a site nearby you."

Answered by AI

Has the FDA greenlit Nivolumab for use in medical treatments?

"According to our assessment, the safety rating of Nivolumab is a 2. This drug has some evidence showcasing its security but no data yet validating its efficacy."

Answered by AI

How many participants are currently enrolled in this medical research project?

"This study has already concluded its recruitment phase, the last update to their trial occurring on October 26th 2022. If you are currently looking for other trials related to colorectal carcinoma and Nivolumab respectively, there are 864 and 949 studies that still need participants."

Answered by AI

Are there vacancies for participants in this experiment?

"This research endeavour is not currently accepting participants. The trial was first uploaded on 12th March 2014 and edited most recently on 26th October 2022. Other available studies include 864 trials searching for patients with colorectal carcinoma, as well as 949 trials that are actively recruiting those who need Nivolumab treatment."

Answered by AI

Are there any published reports of research conducted using Nivolumab?

"At the moment, 949 investigations of Nivolumab are still in progress and 115 have reached Phase 3. While a few studies centered around this drug take place in Pittsburgh, Pennsylvania, there is an array of 49386 locations conducting research on it."

Answered by AI

Who else is applying?

What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

At time of my diaognosis ,my test came back good,but my doctors would not consider any alternative options.They only wanted to do surgery and leave me with a bag.
PatientReceived 1 prior treatment
Recent research and studies
~35 spots leftby Mar 2025